The de-judicializaion of health: mediaion and
interinsituional dialogues
Alexandre Barbosa da Silva 1, Gabriel Schulman 2
Abstract
Based on an examinaion of legislaion, jurisprudence and doctrine, the usual path of requests for medicines in the Sistema Único de Saúde (Uniied Health System) is analyzed, with a focus on requests falling outside the Relação Nacional de Medicamentos Essenciais (Naional List of Essenial Medicines). The usual approach, where the only soluion to a negaive response is the iling of lawsuits, overloads the system, increasing complexity and causing iniquiies. In this context, the present aricle aims to rethink this approach through non-judicial mechanisms of conlict resoluion. Based on the premise that judicializaion is neither born nor ends in the judiciary, measures to “de-judicialize” health are considered: the adopion of mediaion chambers outside the protocols of the Uniied Health System and prior to judicial demands; the reinforcement of interinsituional dialogue between eniies such as the Defensoria Pública (Public Defender’s Oice), the Ministério Público (Public Prosecutor’s Oice), the Secretaria de Saúde e Núcleos de Apoio Técnico dos tribunais (Health Department) and the Núcleos de Apoio Técnico (Technical Support Centers) of the Courts; and the expansion of non-judicial channels, facilitaing access, reducing non-treatment expenditure, and improving public health. Keywords: Judiciary. Public health. Judiacializaion of health. Health care evaluaion mechanisms.
Resumo
(Des)judicialização da saúde: mediação e diálogos interinsitucionais
Parindo do exame da legislação, jurisprudência e doutrina, analisa-se o trajeto usual dos pedidos de medicamentos no Sistema Único de Saúde, enfaizando-se solicitações fora da Relação Nacional de Medicamentos Essenciais. O roteiro usual pelo qual a única resposta às negaivas é a propositura de ações judiciais onera o sistema, torna-o complexo e potencializa iniquidades. Nesse contexto, procura-se repensar essa sistemáica parindo de mecanismos não judiciais de solução de conlitos. Com base na premissa de que judicialização não nasce no judiciário e nele não termina, consideram-se medidas para “desjudicializar” a saúde: adoção de câmaras de mediação além do protocolo do Sistema Único de Saúde e antes das demandas judiciais; reforço do diálogo interinsitucional entre enidades como Defensoria Pública, Ministério Público, Secretaria de Saúde e Núcleos de Apoio Técnico dos tribunais; ampliação das vias não judiciais, facilitando o acesso, reduzindo gastos não desinados ao tratamento e aprimorando a saúde pública.
Palavras-chave: Poder judiciário. Saúde pública. Judicialização da saúde. Mecanismos de avaliação da assistência à saúde.
Resumen
(Des)judicialización de la salud: mediación y diálogos interinsitucionales
A parir del examen de la legislación, la jurisprudencia y la doctrina, se analiza el trayecto usual de los pedidos de medicamentos en el Sistema Único de Salud, con énfasis en las solicitudes por fuera del Listado Nacional de Medicamentos Esenciales. El iinerario usual, a parir del cual la única respuesta a una negaiva es la proposición de acciones judiciales, torna costoso al sistema, lo vuelve más complejo y potencia las inequidades. En este contexto, se procura repensar esta sistemáica pariendo de mecanismos no judiciales de solución de conlictos. Asumiendo que la judicialización no comienza ni termina en el Poder Judicial, se consideran algunas medidas para “desjudicializar” la salud: la implementación de cámaras de mediación además del protocolo del Sistema Único de Salud, previo a las demandas judiciales; el reforzamiento del diálogo interinsitucional entre enidades como la Defensoría Pública, el Ministerio Público, la Secretaría de Salud y los Núcleos de Apoyo Técnico de los tribunales; y la ampliación de las vías no judiciales, para facilitar el acceso, reducir los costos en gastos no desinados al tratamiento y mejorar la salud pública.
Palabras clave: Poder judicial. Salud pública. Judicialización de la salud. Mecanismos de evaluación de la atención de salud.
1. Doutor alexxandreb@uol.com.br – União Educacional de Cascavel, Cascavel/PR. 2. Doutorando gabriel@schulman.com.br –
Universidade Posiivo, Curiiba/PR, Brasil.
Correspondência
Gabriel Schulman – Universidade Posiivo. Departamento de Direito. Rua Professor Pedro Viriato Parigot de Souza, 5.300 CEP 81280-330. Curiiba/PR, Brasil.
Declaram não haver conlito de interesse.
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Creaivity is intelligence having fun Albert Einstein 1
The usual route for the provision of medications implies, in practice, that the only alternaive to the denial of a request is the judicial process. The present study seeks to analyze the legal structure that has led to this situaion, and to idenify strategies that can provide concrete alternaives to de-judicializaion. It does not intend to rule out, in any way, the use of lawsuits to discuss access to health.
What is proposed is a rethink regarding the lack of alternaives to a system in which medicaions, which are not listed in the Relação Nacional de Medicamentos Essenciais - Rename (the Naional List of Essenial Medicines), are necessarily denied by health agencies, without room to analyze the singulariies of the therapeuic project in quesion.
This situation emerged from a wider process. The redemocraizaion of Brazil, which brought with it a resigniicaion of the concept of ciizenship, established a wider right to health in consituional form. Furthermore, the resigniicaion of the concepts of health and disease 2,3 brought new aspects to the debate about their meaning and reach. In this sense, the concept of health as physical, mental and social well-being, not merely the absence of disease or inirmity 4 is key, recommended in the
Constitution of the World Health Organization, adopted in Brazil through Decreto 26.042/1948. 4
In this sense, Aricle 196 of the Brazilian Federal Consituion 5 sets out what is determined in Aricle 25, item 1, of the Universal Declaraion on Human Rights 6 in dealing with universal access to health. In fact, the Organic Health Law, Law 8.080/1990 7,
guarantees access to treatments, including the supply of medicines. Far from implying an absence of cost, the structuring of a system that is accessible to the user represents a signiicant porion of the budget. These transiions have also generated a change in people’s view of the judiciary, giving it a prominent role in this transformaion of access to health care and services, which has contributed to intensifying the phenomenon of the jurisdicional presence in health 8,9.
The theme raises numerous and necessary debates and follows diverse vectors, as has been described in diverse doctrinal writings 8 and reiterated judicial decisions. From the point of view of efeciveness and reality, the limits of the right to health are questioned, and require constant revision, whether due to the rapid modiicaion of
medical and pharmaceuical techniques or by the expansionary nature of fundamental rights 10. These characterisics imply both the magniicaion and the percepion that these tasks should be carried out gradually, as a coninuous construcion 11.
Among the most present discussions or arguments are: the impact of these demands on the public budget, disagreements over how to spend and manage resources, cost increases, the reservaion of the possible 12-14, provisions for judicial measures and the existenial minimum. As is said with simplicity but wisdom, health is priceless, but has a cost, which makes the debate about its extent a constant challenge. Thus, the expansive vocaion of the right to health requires a constant rethinking of its meaning and limits.
In the operaional ield, there has been an increase in the rigor, scieniicity and organizaion of the system, with the importance of the Comissão Nacional de Incorporação de Tecnologias - Conitec (National Commission for the Incorporation of Technologies) in the Sistema Único de Saúde - SUS (the Uniied Health System), dealt with in Aricle 19-Q of the Organic Health Law 7. Signiicant progress
has been noted regarding the factual realizaion of access to health by judicial means, with the concreteness and imeliness of decisions favorable to the paient avoiding the loss of rights and ensuring efecive protecion 15. Nevertheless, it is possible to perceive repeated excesses in the graning of such decisions, due to the lack of decision-making criteria (or the inatenion in their applicaion) 16, which compromise public property and the right to health itself 17.
Given this scenario, it is essenial to examine the current procedure of access to the health system. In summary, there is an administrative request that culminates in the provision or refusal of the medicine or treatment, oten based on the criteria of competence (the indicaion that another enity is responsible) or non-coverage under the standard protocol, without ofering alternaives to the paient, even if falling within said protocol. It should not be forgoten that the paient and his/her family members may have litle access to knowledge of the legal situaion or bureaucraic procedures and even less so in relaion to the clinical situaion.
In order to rethink the system, judicial decisions, current legislaion and doctrine were analyzed, seeking to explain how to promote (or deny) access and present alternaives. In summary, the study proposes a kind of escape from the judiciary through direct access, mediaion and
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interinstitutional dialogues. It seeks to avoid judicializaion, especially in the following cases: 1) where the medicine is included in Rename (when approval is mandatory); 2) the cost of the treatment is low and its eicacy is easily demonstrated; 3) there is an alternaive therapeuic opion that fully meets the request of the paient, such as medicines with the same acive principle (generic) that vary only with respect to their commercial name; 4) the use of the Núcleo de Apoio Técnico - NAT (Technical Support Center) of the courts or the database of the Conselho Nacional de Jusiça - CNJ (Naional Jusice Council) allows a resoluion to be reached prior to legal acion through the absolute adequacy of the request.
This adaptaion may even include medicaions outside the standard list, respecting certain criteria, which may involve cost-efeciveness, the in-progress analysis by Conitec, recogniion by the Agência Nacional de Vigilância Sanitária – Anvisa (Brazillian Health Regulatory Agency) or the lack of an alternaive.
Now is the time to think about creative mechanisms that coherently allow access to health and the protection of the public, beyond the judiciary, through instruments of de-judicializaion that harmonize individual and collecive interests, protecing the budget, access and the necessary urgency of health care.
Essenial medicaions and those not included in Rename
Obtaining medicaions under the SUS, as a general rule, presupposes a paient served by the public network with a prescripion from a public health system professional. This is the rule, although it is oten ignored by the judiciary in some districts, both in the federal and state courts. Despite the efforts to structure the system, the volume of health-related acions has increased. This challenge moivated the CNJ to organize so-called “Jornadas de Direito da Saúde” (Health Law Conferences), which sought, among other measures, to distance themselves both from a bureaucraic proile that envisioned an exuberant quanity of procedures and from the naive humanism that ignored the coda that
health is priceless, but has a cost.
Exemplars of this maturation include: 1) the adopion of the requirement of the periodical renewal of the medical report of continuous treatments 18 based on the structural nature of
the decisions that afect it, and the preference for medicines registered by Anvisa; 2) the excepional character of drugs that are not part of the SUS protocol (non-protocolized); 3) the implementaion of the NAT to assist magistrates through experise in health.
However, these eforts have not completely resolved the issue, and the decision to seek legal redress remains focused on the refusal of the Ministry of Health and state and municipal health departments to provide certain speciic drugs and treatments. Under the current regime, public health administrators cannot provide medicines outside the Rename protocol. This results in all situaions without access to treatment being directed towards the judiciary, such as that of a paient who has exhausted the usual alternaives (either due to health limitaions or through not employing them); ciizens who have been denied procedures and medicines that appear in Rename; and completely unsuitable cases.
In other words, a system has been structured in which the judicial route becomes as natural as it is indispensable when faced with any denial, regardless of its nature or perinence. If in the administraive sphere criicism is focused on limitaions, in relaion to the work of the judiciary the concern is very oten based around the potenially excessive graning of permission, and the virtue of the middle ground has been the subject of intense debate. In fact, judicial decisions are oten made so that laws and ordinances are overridden in order to beneit the speciic need of a paricular paient.
From the perspecive of Arenhart 18, these challenges reach as far as the budget, with emphasis on non-compliance with the Law of Fiscal Responsibility, the underfunding of health, and confusion between the loor and ceiling of health contribuions. In consideraion of the precepts of equality, impersonality and even for organizaional purposes, there is (or should be) a preference for dispensing drugs that are part of the SUS protocol. However, in view of the specialist nature of the right to health, the supply of drugs outside Rename has been judicially determined, in a subsidiary manner, where it is demonstrated that the protocol insituted by the SUS is inexistent, inefecive, incompaible or exhausted, in terms of the feasible and reasonable requirements of the paient.
Along these lines, Summary 101 of the Tribunal Regional Federal da 4ª Região (Federal Regional Court of the 4th Region), published in 2016, establishes that for the judicial graning of health beneits not included
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in a pre-established protocol, the prescripion of the atending physician is not enough, and the producion of evidence atesing to the appropriateness and necessity of the request is necessary 19. Considering that the patient is obliged to demonstrate the insuiciency of the clinical protocols, the judicial decision must atenuate and jusify the excepionality. This is the meaning of the jurisprudence of the Supreme Federal Court, as illustrated, for brevity, in comparison with the following:
Regulatory appeal in extraordinary resource with appeal. Administraive. Provision of medicaion. Joint responsibility of federated eniies. Reairmaion of case-law under the system of general repercussion. RE 855.178-RG. Supply of medicine outside SUS list. Possibility. Ofense to the principle of separaion of powers. Non-occurrence. Regulatory appeal
disproven 20.
In line with this, Statement 4 of the I CNJ Health Law Conference emphasized that Protocolos Clínicos e Diretrizes Terapêuicas – PCDT (Clinical Protocols and Therapeutic Guidelines) are organizing, not limiing, elements of pharmaceuical delivery. Thus, in the speciic case, when all the therapeuic alternaives foreseen in the respecive PCDT have already been exhausted or are unfeasible to the clinical situaion of the SUS user paient, according to the principle of art. 198, III, of the Federal Consituion, the supply by Sistema Único de Saúde – SUS (Naional Health System) of the non-protocolized drug can be judicially determined 21.
This means that, in the current insituional coniguraion, the judicial route becomes the rule to obtaining medicines outside the protocols of the SUS, requiring the costly proceduralizaion of all involved: the judiciary, public health administrators and the paient, an economic and conjunctural efort of expressive complexity. The Judiciary assumes a new responsibility, that is, of structuring itself with technical personnel to provide opinions, experise and analysis that will serve as a support to the decision. That is to say, not only the interpretaion of the order, but the veriicaion of certain concrete elements linked to the paient’s proile and the treatment that is expected to be obtained.
In turn, the public health administration depends on a complex structure to acquire, store and make medicines available. It should also organize procedures for the applicaion and efectuaion of treatments. When it comes to medicines outside the protocol, the diiculty of operaionalizaion is a challenge that cannot be overlooked. The paient
must bear, in addiion to the inancial cost, the ime burden required to obtain treatment, which is not always quick, even with the protecion of the grant of judicial urgency. The current procedure entails the overlapping of assessments made independently and oten devoid of dialogue.
Even when the paient possesses a report from a SUS professional, a new evaluaion is made by the Secretaria de Saúde (Health Department), (before the denial), followed by the opinion of the NAT atached to the Court and a further expert opinion, all to achieve the same purpose for the same paient. The municipal, state and federal prosecutors, in turn, cannot simply agree to the requests, regardless of the paient’s documents or even the costs of the drugs (unlike, for example, tax foreclosures whose low value allows the state to refrain from acion), allocaing resources, then, to (re)discussing the treatment.
This lagrantly bureaucraic modus operandi
generates a waste of resources, a distrust of the system and the prescribing doctor and disregards the costs of the judicial acion itself 22. All the complex
and official procedure for dispensing drugs and treatments through the judicial process generates substanial expenditure of ime and inancial costs absolutely disproporionate to the interest of the public and private individuals who need to setle their interests in liigaion. This analysis becomes even more complex when it is noted that most of the claims are upheld 23. In other words, it is vital to locate elements and modes of acion that aim to access health services without having to move the enire machine of the judicial system - and the equally complex administraive system - created by resistance to the agreement between paient and public service.
The conlict of interest that arises from this impasse needs to be equilibrated to facilitate resoluion for both sides. It is necessary to relect on shared limits and possibilities aimed at the non-judicializaion of health, and the possibility of decisions without the presence of the Judiciary. A joint approach is necessary, without unreasonable resistance, to reach an adequate, coherent and just route to the implementaion of aricle 196 of the Consituion 5.
Proposals to tackle judicializaion
Summarizing some essential points, the description of the current model allows us to observe a number of symptoms: 1) the prevalence of a judicial soluion in the face of refusals, with a
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large number of individual acions 9; 2) high costs not related to structured treatments within the system; 3) the ime burden on the availability of the drug or treatment; 4) insuicient dialogue between public and private eniies and between diferent spheres of public administration; and 5) overlapping of independent medical assessments.
From this perspecive, it is possible to think of adjustments that can contribute to improving the health system, which is already much more structured than it was during the drafting of the Organic Health Law. Four situations can be identified based on some of the objective suggesions expressed in this aricle. First, the need to consider that judicializaion (here taken as the excessive low towards the Judiciary) cannot be tackled only within the Judiciary, since judicial acions are a consequence, not the cause itself. On the other hand, as they say in the health area, they are side efects:
A strategy used by the Judiciary in some districts has been extrajudicial acion, which extends the possibiliies of its acion and the realizaion of the right to health. This makes it possible to consider the idea of the juridiicaion of social relaions (conlicts are discussed from the legal point of view), without judicializaion necessarily occurring (at best, it avoids bringing conlicts to the Judiciary). As a result of this acion, a valorizaion of dialogue is observed, in order to generate efecive acions in the referral and resoluion of conlicts. In addiion, it contributes decisively to the establishment of a judicial health policy 24.
Moreover, to think only of conciliaion before or during the process, but efected within the scope of the judiciary, at a preliminary or post-trial stage, in a hearing for this purpose, for example, obviously does not avoid the acivaion of the legal machine that one wishes to keep on the sidelines of the discussion. In order to achieve the objecive here proposed, the possibility of administraive spaces that specifically evaluate the concrete cases of paients and can assess the need (or not) to release treatments outside clinical protocols should be borne in mind.
These spaces for extrajudicial debate should preferably rely on the paricipaion of the Public Prosecutor’s Oice, the Federal Public Defender’s Oice and the eniies involved in the supply of procedures and drugs. This perspecive is aligned with the national policy of encouraging self-determinaion, which is based on CNJ Resoluion
125/2010 25, whose purpose is to promote a fair legal order based on public policies for consensual soluions to conlicts. With the same intenion, the Conselho Nacional do Ministério Público – CNMP (Naional Council of the Public Prosecutor’s Oice) issued CNMP Resoluion 118/2014 26.
Administraive mediaion in the area of health has shown itself to be a viable and interesting alternaive 27. Even if, in the absence of resoluion,
the elements produced can form part of the judicial acion. This is contrary to the usual procedure, in which the analysis of the Health Department does not properly integrate with the analysis of a legal judgment, except for the leter of refusal that does not always explain the issues, oten concentraing only on the absence of the provision of the medicine within the clinical protocol.
An example is the “SUS Mediado” (Mediated SUS) project, launched in 2012 in Rio Grande do Norte, which brings together the Defensoria Pública Estadual (State Public Defender’s Oice), the Procuradoria Geral do Estado (State Atorney General’s Oice), the Secretaria de Saúde Estadual (State Health Department), the Defensoria Pública da União (Federal Public Defender’s Oice), the Procuradoria Geral do Município de Natal (Atorney General’s Oice of the Municipality of Natal) and the Secretaria de Saúde Municipal (Municipal Health Department). In short, the format of the project is that:
The mediaion sessions for administraive resoluion of the health issues covered by the program take place every Wednesday through a Conciliation Chamber, composed of a pharmacist, a doctor, a State Public Defender, a representaive of the State and the Municipal Atorney General’s Oice and the person receiving care, who meet at the Headquarters of the Public Defender of the State with the primary purpose of solving the demand extrajudicially, guaranteeing the concrete realizaion of the right to health. Also, through this program, the ciizen who has not had his or her case resolved in the extra-judicial sphere is ensured of the possibility of opposing through his own judicial acion, through a State or Federal Public Defender, to bring his or her rights into efect 28.
Similarly, in 2013, in the Distrito Federal, the Câmara Permanente Distrital de Mediação em Saúde – Camedis (Permanent District Chamber of Health Mediaion) was created to assist in the reducion of lawsuits. According to the Conselho Nacional de Secretários de Saúde (Naional Council of Health
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Secretaries), the growth in the number of lawsuits iled within the scope of the Secretaria de Estado de Saúde do Distrito Federal - SES/DF (the State Health
Department of the Distrito Federal) is approximately 30% each year 29. Joint Ordinance 1/2013 deines, in aricle 2, that the insituional mission of Camedis to ind soluions to the demands for health products and services, with the purpose of avoiding lawsuits or proposing soluions to those in process 30.
From this agreement, it was deined that, before the request, the Health Department veriies if the medicine is included in the SUS protocol. If it does not appear, a therapeuic alternaive is ofered, which allows ciizens to paricipate more actively in the decision-making process, letting them distance themselves from liigiousness, one of the obvious causes of judicializaion. The culture of liigiousness is sill highly present in Brasilia, as is, as a consequence, the adversarial model of the judicial process in the realizaion of the right to health.
However, the results already achieved allow us to understand Camedis as a promising out-of-court strategy. This Chamber focused on three major insituional measures for the realizaion of the right to health: to strengthen space for insituional dialogue starting with the District Committee; consitute a framework for the consensual resoluion of conlicts in health; and empower ciizens through consensual soluions 31.
In Rio de Janeiro, it was deined as a protocol that the Public Defender’s Oice, responsible for a significant portion of legal actions regarding medicaions in the state, should previously consult the state and municipal secretariats in an atempt to obtain such medicaions through the administraive route. If this is not feasible, legal acion can be taken. In the same state, in agreement between the State and Municipal Health Departments and the Rio de Janeiro State Public Defender’s Oice - the body responsible for most of the medicaion requests in the state - established a low that facilitated the supply of medicines. Based on this consensus, the procedure adopted was:
When the paient wishes to ile a suit for medicaion or health supplies under state or municipal jurisdicion, the Oice of the Public Defender’s Oice should request a medical report from the Uniied Health System and before iling the acion should send a leter to the federaive eniies quesioning whether the requested item is available. If the state and/or municipality has the drug or supply, they should contact the paient and schedule its delivery,
communicaing the fact to the Public Defender’s Oice. Only in response to the negaive response of public eniies should legal acion be proposed 32.
The rapprochement of eniies is fundamental, and dialogue among administrators greatly facilitates the gradual change of public policies. These interfaces allow us to better understand and address the origins of the problem, including rethinking government strategies. It is even possible to take advantage of previous experience of cases in which drugs and treatments were later granted in court, with suicient grounds, to change public policies. It is not a mater of supporing rampant judicial acivism, but of re-establishing the dynamic character of checks and balances. It is a quesion of disinguishing acivism from judicializaion, due to their obvious philosophical peculiariies 32.
In this regard, Amaral 10 recommends that individual judicial demands be used to raionalize the system: if the Judiciary, instead of replacing the decision of the public agent with its own, demands from the former the rapid jusiicaion of its choices and procedures and, by the end of this deadline, evaluates the reasons given, although not necessarily abiding by them, perhaps a great step is being taken towards a greater realizaion 33.
The very possibility of procedural legal antecedents can serve as a valve to consider the procedures comprehensively, according to aricle 190 of the Código de Processo Civil – CPC (Civil Procedure Code) 34. On the feasibility of a legal transacion involving the Public Prosecutor’s Oice and the Fazenda Pública (Treasury), Statements 253 and 256 of the Permanent Forum of Civil Proceduralists is recommended reading 35.
Today, access to justice no longer follows the “quanitaive” style, which originated in the “Florence Project” of 1973 under the guidance and leadership of Cappellei 36, which sought to facilitate the judicializaion of pretensions, prevening paries from failing to assert their access to the judiciary to secure their rights. This took place in the reforms of the CPC of the 1990s, and especially with the creaion of the special courts.
The process should be instrumental, with it falling to the judge alone to consider the applicaion of the (uniform) values of society, and perhaps even making alternaive use of the law 37. This led to flagrant exhaustion of the conditions of the judiciary to meet the minimum intenions within a suitable ime and condiions. A potenially efecive route, which is spelled out in the new CPC, is that of
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“qualitaive” access to jusice 36 which considers not only the proper results of the process, but also the saisfacion of the claims through extrajudicial and consensual channels of acion.
Secondly, based on the premise that judicialization does not begin or end with the judiciary, what can be called “inter-insituional dialogues” should be encouraged and put into pracice. There is currently a chasm between the various spheres involved in the procedure: the paient must obtain a prescripion from the SUS doctor, which is then considered by a doctor of the NAT. Next, the same is evaluated by an expert physician, and there is also the possibility of the prescripion being conferred by more than one SUS doctor. The redirecion of this model, in order to avoid overlapping of actions and to confer difereniated credibility to the doctor within the judicial sphere, seems to be more in line with consituional precepts.
It is not only this. In the extra-judicial sphere, with the creaion of mediaion chambers and procedures, the theme will be treated in a multidisciplinary manner by the diverse framework of legal decisions that make up the SUS, with the possible paricipaion of the Public Prosecutor’s Oice. The inter-insituionalizaion of the procedures, in relaion to the (extrajudicial) consensual resolution of the conflicts, will give greater security to public eniies and facilitate the access to health by the populaion. This will require goodwill and cooperaion among those involved.
It is not coherent to imagine that the combination of efforts leads through different means to the best decision-making technique for the dispensaion of health. Once several experts have evaluated the concrete situaion, the result tends to be to use the best technical-scieniic decision to adapt the treatment to the individual, allied to the reasonable cost that is bearable by the system, with the urgency depending on the peculiariies of each case.
Thirdly, the measures of access to health involving intellectual property law have not yet been suiciently observed. It should be remembered that the law provides for possibilities such as compulsory licensing, that is, acquisiion through payment, unfortunately confused with some form of expropriaion, hence the frequent use of the term “patent infringement”. Finally, as a fourth element for relecion, the quesion of the costs of public health provision in the current model is considered. With the increase resuling from judicializaion,
public eniies have been obliged to create large and costly structures to comply with orders resuling from judicial decisions.
Budgets were utterly torn apart due to the impossibility of forecasing the amounts to be spent through these determinations arising from judicialization. The costs of legal actions are exorbitant at all levels, from the values of the health procedures themselves to amounts such as late fees, costs, lawyer payments and the other costs of legal acion. Undoubtedly, it would be less costly to ofset these expenses by convering part of the exising structure to the creaion of centers for the consensual evaluaion of public health acion requirements.
Health expenditures, which are already high, should focus mainly on the cosing of treatments, concentraing on investment directly linked to health and, where possible, prevenion. It is also necessary to increase primary health care, as opposed to the judicial process.
In addiion, it is necessary to consider the cost of the system in relaion to the demand and the costs of judicialization themselves. Extra-judicialization therefore constitutes a relevant channel for reallocaing resources. Reducing judicial liigaion leads to the saving of public resources, concentraing expenditures on the real objecives of public policies (health), and promotes the most important mater: beter care for people in need of health services.
Extrajudicial chambers for mediaion of health procedures
Iniially, four premises were briely developed: avoid the judiciary; dialogue between SUS administrators; medicaion procurement techniques through compulsory licensing (which many insist on designating “patent infringement”); and consideraion of structural costs.
From these, it may be possible to formulate a proposal for reflection on a possible method for structuring a consensual and out-of-court soluion to conlicts involving public health at state and municipal levels. It is perfectly feasible to preempively solve many of the issues that currently end up being handled by judicial measures based on the common efort of those involved in yielding, where appropriate, to obtain the relevant beneit intended. In this sense, Carlini suggests:
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Conflict resolution by non-judicial mechanisms can be interpreted as a sign of the maturity of an organized society, because it ataches importance to dialogue and the weighing of arguments rather than the search for a soluion dictated by magistrates who will not always have the objecive condiions to take into account the impact of their decision on the whole of the public or private society 38.
It is possible to discuss processes that reassess the possibility of administraive measures for health procedures not provided for in the SUS protocols. One of the tools is to structure “mediaion chambers” and health procedures, composed of mulidisciplinary teams, within the state and municipal structures. The paricipaion of a representaive of the Union - with the funcion of analyzing requirements regarding health actions that are outside the possibilities described in the clinical and therapeuic protocols of the SUS - should also be considered.
After the rejection of the administrative requests issued to the Secretaries of Health, the chambers will come into play. These eniies will carefully analyze the procedures, evaluaing the possibility of granting - independently of the judicial process - the health acions required and jusiiably denied.
The rejections can be reanalyzed from criteria that are more legal than clinical (medical or pharmacological), objecively involving concrete cases. In other words, the ime, money and other resources that would be applied to the work of legal proceedings will be subsituted by probaive production and the administrative decision will replace that would be reached in the courts. To do so, two operaional measures must be adopted: 1) consituion of the chamber and its personnel structure; 2) details of procedures.
Establishment of the mediaion chamber and health procedures
The creaion of the chambers can happen in federal, state or municipal administraive spaces, according to the demands of each federaive enity. The most appropriate approach is that these will be structured from the exising organizaion that manages the treatment of the results of the lawsuits, through the experience of the employees and the appropriate structural arrangement.
Equally propiious would be representaives of the State and Municipal Health Departments, the
State and the Municipal Atorney General’s Oice, the Ministry of Health, the Advocacia-Geral da União
- AGU (Brazilian Oice of General Atorney), the Public Prosecutor’s Oice and the public defender’s oices. In addiion, of course, to experienced medical praciioners such as experts and representaives of the NAT.
It is not, therefore, intended to ignore the advances achieved, but to incorporate them, by considering whether the judicial route will be indispensable when the substantive discussion depends on medical aspects. Nevertheless, considering the equally pracical interest of this trial, the easiest and most urgent approach could be the creaion of these chambers by the states and municipaliies within their judicial prosecutor oices, with the paricipaion of qualiied professionals from the Health Departments.
This is because the intenion at this moment is more about the legal analysis of the feasibility of prevening liigaion than the health specialies themselves. Thus, it seems coherent to suggest that the team formed for this purpose focuses on the legal technique, in the sense of analyzing compliance with the setled or majority decision criteria that have guided judicial actions in the granting of verdicts, reaching, in advance and preventaively, administraive measures that “save” those involved in typical liigaion.
Standardizaion and detailing of procedures
The structuring of an extrajudicial system aims to overcome the “system of all or nothing”, that is, where either the protocol of the SUS is followed or legal acion is sought. If, on the one hand, the change of raionality is signiicant, its implementaion does not require profound changes. The start of the path remains the same, beginning with the request for release of the treatment by the paient. What changes is the second step, where, faced with a negaive response, the individual does not directly seek legal acion. What is suggested is a complete chamber composed of representaives of all the public eniies involved in public health measures.
This would assume the status of an extrajudicial assessment panel, which is responsible for analyzing the factual situaion in the light of the needs and singulariies of the paient, described in the medical record and prescripion of a SUS health professional, or, if jusiied, by a private physician. The excepional request - ater the refusal of the Health Department - that authorized the procedure described herein being sought must be accompanied by all documents and elements that
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serve as proof of the modiicaion of the previous decision. In addiion, they must follow NAT opinions, CNJ recommendaions, health commitees, setled jurisprudence (or known majority) of the courts, among others.
Upon such request and documentaion, the collegiate shall defend or administraively revoke the excepional request, by means of a reasoned decision. If it is considered perinent, the interested paient will be allowed to produce other tests. If further opinion is required, the collegiate may refer the case to an oicial doctor for demonstraion. Valuing extra-judicializaion, let it be clear, does not contradict the consituional right to a lawsuit. The development of mechanisms that facilitate the evaluaion of singulariies, without prejudice to the evaluaion of medical foundaions, does not make the judicial sphere indispensable.
Even if a lawsuit is subsequently lodged for the same reason, it will be based on the appropriate evideniary content, falling within the due administraive procedure, which will allow a fair and technical debate within the judicial process. It is reasonable, however, and also advisable, that where possible the suggested chamber be created in state and municipal prosecutor departments, as these state representaives deal with judicializaion and its results on a daily basis. The Chamber of Mediaion and Health Procedures shall be created by law or substaniate its acions in exising law, due to the necessity of the handling and desinaion of public funds being speciied in this normaive structure.
Final consideraions
The increasing volume of lawsuits in health is notorious. It is considered that part of the problem is in the way the system has been organized, adoping imperaive treatment protocols, which, while on the one hand are fundamental to the organizaion of the system, on the other, drive judicial acions. In the administraive sphere, the system coexists in large part with the reducion of possibiliies (the “administraive request, refusal, lawsuit” that no longer applies). In general, either the paient follows the usual protocol or cannot have their request met, even when the therapeuic alternaive ofered is not suitable due to being exhausted, inappropriate, insuicient or inefecive.
There are solutions to the judicialization of health, but they require the acceptance of criicism of the phenomenon in its muliple meanings in a
construcive manner. The frequent argument regarding the separaion of powers gives way to the appreciaion of the “checks and balances” 39 and the dialogues between diferent eniies, forming genuine service networks. The usual censorship of the Judiciary’s interference in public policies is not resolved by the impossibility of access to the judicial sphere, but by the provision of real and concrete alternaives.
However, it is not intended here to deconstruct the exising system, nor to reject NAT or other current mechanisms. What is recommended is a new step that ilters medicaion cases outside the protocol, but with lower costs and proven efeciveness. Recogniion of the right to a given treatment, both at the administraive level and at the judicial level, depends on the speciic situaion of each paient. Emphasizing prescripions, even outside the protocol, values fundamental iltering that, as shown, will not prevent access to judicial channels. On the contrary, it will make it more qualiied.
It is also worth commening on the important repercussions to the quesion of access to medical treatment in the higher courts. The First Secion of the Superior Tribunal de Jusiça - STJ (the Superior Jusice Court), in assessing special appeal no. Resp 1657156/RJ, considered the need to apply the case to the system of special repeals 40, that is, to establish a soluion that could be applied to several cases in which the same legal mater is discussed. In a mater of order presented at the trial session dated 05/24/2017 and published in the Diário de Justiça (the Justice Gazette) dated 05/31/2017, the topic to be debated was designated “The obligaion of public power to provide medicines not incorporated in normaive acts of the SUS” 41. In
addiion, the naional suspension of all outstanding cases, individual or collecive, on the mater, was determined, except for urgent maters on the supply of medicines.
It is considered that the SUS protocol is preponderant in character, but it should not be taken as having a limiing role of access to health. Access outside the SUS protocol requires, in an essenial manner, adequate proof of the need and speciic jusiicaion of each clinical case, such as the hypothesis of the non-existence of a therapeuic alternaive in the SUS, or the failure, incompaibility or impossibility of coninuity of drug use adopted in public policies.
It is also important to emphasize that the Supremo Tribunal Federal - STF (Federal Supreme Court) is currently discussing the “duty of the state to
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provide a high-cost drug to a person with a serious illness who does not have the inancial condiions to purchase it.” This is an equally central quesion 42.
Among other aspects, it is considered central to invesigaing the very meaning of high cost and its confrontaion with other elements. This sets the challenge of the collaion of muliple factors, including survival ime, risks, presence of palliaive character, the existence of alternatives and their effects (including collateral).
To conclude, it is useful to offer a simple recommendation: the more the doctor justifies his opinion, the less medical the judge needs to
be. Challenges are set and tradiional soluions
should not be overlooked. One cannot deny the insuiciency of the current model, the potenial for new soluions, the great possibiliies of using (more) adequate forms of conlict resoluion, and the need for a joint efort to adopt efecive remedies for the realizaion of the right to health.
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Paricipaion of the authors
The authors paricipated jointly in all the stages of the creaion of the text, including its concepion, bibliographic research, and the wriing and revision of the aricle.
Recebido: 4.11.2016 Revisado: 10. 3.2017 Aprovado: 8. 4.2017
